Contraceptive development process and quality of care in reproductive health services

International Women's Health Coalition
P.O. Box 8500
New York, NY 10150 USA

The Population Council
One Dag Hammarskjold Plaza
New York, NY 10017 USA

The Contraceptive Development Process

and
Quality of Care in Reproductive Health Services

A Meeting Held in New York City
October 8-9, 1986

The Contraceptive Development Process
and
Quality of Care in Reproductive Health Services

Rapporteurs' Report of a Meeting Sponsored by the
International Women's Health Coalition
and
The Population Council
New York, New York

October 8-9, 1986

ACKNOWLEDGEMENT

These activities were supported by the General
Service Foundation, the International Women's Health
Coalition, and The Population Council.

TABLE OF CONTENTS

INTRODUCTION .................... 1

RESOURCES FOR AND PRIORITIES IN CONTRACEPTIVE DEVELOPMENT. 5

1. Funding for Contraceptive Research. . . 6

2. Determination of Contraceptive Research Priorities. 8

3. Points of Consensus on Contraceptive Development. .. 9

4. Issues for Further Discussion and Definition
of Desirable Actions on Contraceptive Development 16

QUALITY OF CARE FOR THIRD WORLD FAMILY PLANNING CLIENTS. 20

1. Points of Consensus on Quality of Care. . .. 22

2. Issues for Further Discussion and Definition
of Desirable Actions on Quality of Care ...... 27

THE NEXT STEPS ...................... 28

)NICES

I Agenda . . . . .

II "Two Decades of Contraceptive Research:
Prospects for the 21st Century"
by Linda E. Atkinson, Ph.D . .

III "Quality of Care in International
Family Planning: A Feminist Contribution"
by Deborah Rogow, MPH . .

IV List of Participants . . .

* 29

* 33

* 72

. 103

APPE!

INTRODUCTION

Building on a workshop in March 1985, the Population

Council and the International Women's Health Coalition

initiated the October 1986 meeting to encourage dialogue

between the international family planning field (developers

of contraceptives, managers of contraceptive introduction,

and family planning service providers) and women's health

movement representatives from the US and developing

countries. The basic premise is that family planning

professionals and agencies have access to important

scientific information and service delivery resources that

need to be shared at an earlier rather than a later date with

women's health groups. Equally, the perspectives of women's

health groups, their knowledge and contact with women both in

the United States and in developing countries, need to inform

the work of the population field.

The agenda, papers, and other presentations, and the

participants were determined by a small working group that

included International Women's Health Coalition (IWHC) and

Population Council staff, leaders of the Boston Women's

Health Book Collective, and a feminist health advocate with

public health expertise and domestic and international

experience. This group worked on the basis of an agreed

statement of concern as follows:

"In both the industrialized and developing
worlds, we value women's rights to reproductive
choice and we are committed to the highest quality
and widest range of choice of reproductive health
services for all women, without coercion,
incentives or undue persuasion. We are equally
committed to making available the most complete
information about reproductive health and human
sexuality, as a matter of human rights and
informed consent. Such information includes
risks, benefits, and short- and long-term
consequences, both intended and unintended.
Reproductive rights include the right of refusal
of any and all services or products. We believe
these values need to be further explored,
elaborated and given more concrete substance."

Further, the planning group envisioned dialogue, and

possibly collaboration, between the population establishment

and the women's health movement as an important means to

counter both the Far Right's efforts to curtail reproductive

choice and also the rising belief, from some quarters, that

more coercive population control measures are needed. Noting

the importance of international assistance for family

planning, the planning group, as individuals, have objected

strenuously to the Far Right's attempt to use women's

concerns about contraceptive safety and the quality of family

planning programs, here and abroad, in the Far Right's effort

to curtail United States support for family planning programs

and for contraceptive research worldwide. The group has also

noted some increases in instances of violation of human

rights in order to achieve reduction in the population growth

of specific groups.

The dialogue on October 8-9 sought, among other tasks,

to identify some commonly held principles and concerns that

could serve as a point of departure for compatible and

reinforcing public postures by proponents of family planning,

population control, and women's health.

On the premise that the risks and benefits of specific

contraceptive technologies are determined not simply by their

intrinsic characteristics but also by availability and

quality of health services, among other key factors, the

working group developed a two-day agenda (Appendix I). The

first day was devoted to discussion of the contraceptive

research and development process; the second, to discussion

of existing family planning delivery systems in developing

countries, and ways in which the quality of reproductive

health services can be improved, especially in the Third

World.

The working group commissioned a background paper and

presentations for each day with an eye to balancing diverse

viewpoints. The commissioned papers are enclosed as

Appendices II and III. Similarly, participants were chosen

to represent varying perspectives. The number was limited to

thirty-one to encourage as much dialogue as possible. A list

of participants is enclosed as Appendix IV. Half the

participants are actually engaged in service delivery: seven

are from Third World countries, and eight are engaged

directly or indirectly in contraceptive research.

The intention of this report is to share, with a wider

audience, both the points of consensus and the issues that

need further discussion before the two groups can develop a

basis for common action. The audience for the report includes

the family planning and population field, the women's health

movement in the US and overseas, the major donors in the

field, and also professionals and contractors who work

internationally on these issues.

RESOURCES FOR AND PRIORITIES IN
CONTRACEPTIVE DEVELOPMENT

The lead paper was prepared by Dr. Linda Atkinson, an

acknowledged expert in the field of contraceptive

development. Updates on barrier methods and RU 486 were

presented, respectively, by Dr. Henry Gabelnick of the

National Institutes of Health (NIH) and Dr. Irving Spitz of

the International Council for Contraception Research (ICCR)

of the Population Council. These presentations were intended

to inform all participants of the current state of research

on each method, the most likely leads for the next ten years,

and the prospects for sustained research. Each presenter

gave particular attention to US regulatory and funding

requirements, their effects on the entire research process,

(from setting research agendas to the final stages of

clinical trials), and the need for a concerted public voice

in support of increased resources for contraceptive

development and diversification of research approaches.

The participants' general comments on the state of

research focused on factors affecting overall funding for

contraceptive research and development, and on women's health

advocates' perspectives on research priorities and on

contraceptive safety.

Generally, participants noted that contraceptive

research serves at least two very different markets: women

in the US and affluent women in the Third World on the one

hand, and poor women in the Third World on the other hand.

Investment has tended to focus on methods that are long-

lasting, highly effective, and easy to deliver. Methods with

intrinsically lower risks to health but with higher risk of

failure due to faulty use have received less investment.

Recurrent themes in the discussion were, therefore, the

prospects for making high-technology contraceptives less

risky to health and subsequent fertility, and the prospects

for improving the efficiency and acceptability of

conventional (barrier) methods.

1. Funding for Contraceptive Research

Participants reviewed major factors affecting funding,

particularly US government regulations for human research.

Because the consumers are usually healthy people, US

regulatory requirements are appropriately stringent.

Research is therefore extremely time-consuming and expensive.

Recently, overall costs have skyrocketed due to lawsuits

concerning both short-term and long-term contraceptive safety

and side effects. In these US suits, little legal

distinction has yet been made between damage resulting from

gross negligence and deceit, as opposed to damage from the

experience of known risks by informed users. The insurance

industry, in response to claims against contraceptive

developers and manufacturers, has argued that they must raise

their premiums and in some instances withhold coverage of

contraceptive research altogether. (US insurance industry

critics argue that litigation is not the problem, and that

the industry is using litigation as an excuse to raise

premiums.)

In the present US legal and insurance environment, the

private pharmaceutical industry is withdrawing from research,

clinical trials, and marketing and distribution,

substantially reducing both funds and expertise available for

contraceptives. US government and private research

institutions, such as the International Council for

Contraception Research (ICCR), cannot themselves produce and

market contraceptives even when approved by the US Food and

Drug Administration (FDA). Consequently, some methods,

including some barrier methods, exist and have FDA approval,

but are not available. Government funding for research is

further limited by restrictions on research on methods that

might in any way act as abortifacients.

Overall, government funding has declined in real terms

(see Appendix II). The organized public voice in support of

contraceptive research and development must be strengthened.

2. Determination of Contraceptive Research Priorities

Contraceptive researchers and family planning service

providers have, for the most part, been guided by the promise

of technologies already under development, and their own

interpretions of "users' perspectives" on safety and other

characteristics of contraceptives. The women's health

movement, and users more generally, have had few

opportunities to participate directly in the determination of

research priorities and standards. Rather, their involvement

has tended to become visible only through critiques in the

press and the courts, and has tended to focus substantially

on problems, rather than solutions and the fundamental need

for safe, effective means of birth control. (An important

exception is the cervical cap. In this case, women's health

advocates have worked on both research and approval.)

Major recurrent themes in the discussion were "safety,"

"risk," and "effectiveness," and also users' perspectives on

desirable contraceptive characteristics. Users, especially

women's health advocates, tend to place very high priority on

lowering the relative risks of methods and a lower (though

not low) priority on effectiveness. A method's risk for a

particular woman is multifaceted. At least three elements

deserve attention: the risk of pregnancy when using the

method (method efficacy), side effects from the method

itself, and the ways in which service delivery systems screen

for, compensate for, or intensify the intrinsic risks of a

method.

3. Points of Consensus on Contraceptive Development

Underlying the discussions was a recognition that

individual women's contraceptive choices are affected by and

reflect complex interactions of their personal situations,

the intrinsic properties of technology, the conduct of

service providers, and the societal context of policy and

human rights. Out of a recognition of these complexities, a

number of points of consensus emerged.

We should not expect or look for the "perfect"
contraceptive, but should seek instead to expand
the range of "good" methods.

No "perfect" contraceptive for all women is ever likely

to exist. Women's needs are determined by their variable

age, parity, lactation, marital status, other biological and

social characteristics, the cultural and economic setting,

and the availability of health services, as well as by

women's knowledge of contraceptive methods. "Good" will be

defined differently by different users who make varying

trade-offs among contraceptive efficacy, safety, and

convenience, among others. These trade-offs may be seen

differently by other actors: funders, researchers, providers,

governments, those concerned about high population growth

rates, the pharmaceutical industry, and marketing agencies.

Participants, especially the women's health advocates, shared

interest in diversifying contraceptive choices. Many felt

that diversity should not come simply from "high-tech"

methods, but also from improved conventional methods and

improved delivery systems. Considerable attention was given

to (though no consensus was reached on) judgments required in

deciding whether a contraceptive is good enough to market

(When is it effective enough or safe enough?), or deciding

when a lead is appropriate and strong enough to warrant more

intensive pursuit (e.g., RU 486).

The appropriateness of contraceptives to a given
setting is conditioned by the extent and quality
of supportive health services.

Especially for women in the Third World and for poor

women in the US, basic health services, in particular those

for all aspects of reproductive health care (abortion, STDs,

prenatal, delivery, postnatal), may be rudimentary at best.

Proposals to introduce contraceptives that require contact

with a skilled provider (and often submission to a clinical

procedure), in settings where health providers and services

are limited, should carefully assess the capacity of the

health system to provide skilled personnel and necessary

backup. Health services should be adequate to deliver the

methods, and to cope with contraceptive side effects --

including those generated by the methods themselves and those

that result from poor or improper delivery.

Although there is no single "women's view" (or
"user perspective"), the contraceptive research,
development, and distribution processes would be
greatly enhanced by closer consultation with
women's health advocates worldwide.

Several methods to accomplish this include, among

others, informal but regular consultations between

researchers and women's health advocates, and formal

inclusion of users or other representatives in contraceptive

research review boards. In evaluating which generic types of

contraceptives bear further development, particular attention

should be given to learning what levels of risk are viewed as

acceptable. Variation is to be expected in this. For

example, some women's health advocates question whether the

risks involved in IUD use are ever justifiable; others

recognize the IUD as an important choice for some women at

some stages in their reproductive lives.

The development of new contraceptives necessarily
involves clinical trials that entail risks for
women study subjects. While some risks may be
unforseeable, volunteers should be judiciously
screened and provided with full information on the

experimental nature of the drug or device and
expected side effects. Trials should be carefully
monitored.

Procedures for providing information, obtaining

"informed consent," and assessing users' views and

satisfaction, even when well defined in principle, are often

implemented poorly. Emphasis needs to be given not only to

the definition of standards but also to the implementation of

them, which requires both money and commitment. In countries

that do not generally recognize consumer rights or have

adequate drug regulations, this task will be especially

challenging, but no less important. Women's responses and

reactions to methods under trial should be fed back into the

research process systematically in order to affect research

priorities.

Whereas some contraceptive methods are developed
with the perceived needs of the Third World as a
priority, it is important that contraceptive
trials include relatively advantaged First World
women as well as women of color and Third World
women.

Though there continue to be misunderstandings about and

misinformation on this subject, some improvement in

procedures has been made to ensure against exclusive use of

relatively "disadvantaged" women for clinical trials.

Different clinical populations of women, even within the same

country, may have markedly different levels of acceptance and

continuation with the method under study. Thus it is both

analytically valuable and ethically necessary to continue to

test new therapies in multiple First and Third World

settings. It should be noted that no drug obtains US FDA

approval until it has undergone clinical trials among

American women.

Public education about the risks and unknowns
associated with a new method should begin before
its broad-scale introduction. Contraceptive
surveillance programs that track the experience of
large groups of users of newly approved drugs
should be encouraged, strengthened, and
publicized.

When broad marketing begins, consumers should be

systematically informed about known risks, both absolute and

relative to other methods and to no method use. In addition,

provisions should be made to monitor the effects of the

contraceptive on larger populations of women whose

contraceptive use and ability to control births are affected

by socio-economic variables, women's status in that society,

their dietary practices, male attitudes, and the state of

national and local health services. Cases in point include

the discovery of the linkages between smoking, age, and side

effects of oral contraceptives; identification of

contraindications for IUD use; and the need to modify oral

contraceptive dosages to minimize side effects.

"Safety" will always be relative to the objectives
of contraceptive use, the alternatives, and the
individual's health profile.

Some types of research and some contraceptives entail

more risks than others; individual users vary with regard to

the level of risk they are willing to accept. Furthermore,

since contraceptives are used by healthy people,

contraceptive users may reasonably accept much less risk than

those in ill health. In contrast, cancer patients, for

example, may be willing to accept experimental therapies with

very toxic side effects.

As the range of contraceptive choices is narrowing
owing to funding, insurance, and political
problems, among others -- it is especially
important that delivery systems provide the
fullest possible range of approved methods.

Many service delivery programs do not adequately explain

the range of methods, describe their specific

characteristics, or encourage dissatisfied users to switch

methods. Clients cannot reap the benefits of advances in

contraceptive technology unless delivery systems both provide

information on and make available a broad range of methods.

Equally, counselling and education should give attention to

the emotional and psycho/social dimensions of birth control,

in a manner that is culturally and socially acceptable.

Issues of sex and sexuality are integrally related to birth

control and must be acknowledged by those who deliver

services. It was agreed that men's use of contraceptives,

especially the condom, should increase -- as a way of sharing

reproductive risks with women and reducing the spread of

sexually transmitted diseases.

The past decade's emphasis on "high-tech,"
provider-dependent methods has reduced family
planning providers' knowledge of, and in some
cases trust in, user-employed methods.
Researchers and service providers, together with
women's health advocates, need to help renew
support for user-employed methods (condoms,
spermicides, diaphragms, etc.) and practices to
ensure a full range of birth control choices.

Barrier methods have high efficacy among trained and

committed users, carry minimal intrinsic risks to health, and

have the strong advantage of providing some protection from

sexually transmitted diseases. Many can or could be provided

outside a clinic setting, enhancing accessibility.

Culturally accepted and readily available, widely used

traditional methods -- breastfeeding, withdrawal, rhythm,

abstinence -- should not be denigrated on the grounds of

"theoretical" efficiency, as some women and men may be able

to use them efficiently, and the choice should be available.

Specific strategies need to be worked out on
abortion and on research on methods that act as
abortifacients, because US government funding
restrictions are already substantial, and various
groups worldwide seek to restrict research and
services even further.

Sustained effort is needed to generate support for

research on RU 486 and on abortifacients more generally. It

was acknowledged, however, that as important as abortifacient

research is, clinical abortion services are currently in

jeopardy and must be maintained. Both research and services

require not simply lobbying efforts to counter those who

would eliminate funding but also efforts to overturn existing

restrictive legislation.

4. Issues for Further Discussion and Definition of Desirable
Actions on Contraceptive Development

Provider-dependence, a characteristic of many
"modern" contraceptives (injectables, implants,
IUDs), challenges service delivery systems to
adequately protect women's health and rights.
Provider dependence can be a major drawback where
delivery systems are weak, careless, or operate in
a coercive context.

In general, a spectrum of responses to provider

dependence is possible: steps can be taken to assert women's

right to remove the method on demand, to monitor programs to

ensure that this is done, and to provide full information to

the user and actively encourage her to withdraw whenever she

wishes. In addition, making a wide range of contraceptive

choices available will help ensure against provider bias.

Alternatively, methods that are dependent on providers for

both initiation and termination can be discouraged

altogether.

Views on the advisability of taking any of these

postures on a specific method varied. The methods discussed

in greatest detail were injectables, the subcutaneous

hormonal implants, and IUDs. For example, clinical trials of

NORPLANT (the Population Council's registered trademark for

contraceptive subdermal implants) are well advanced. Some of

these are supervised by agencies with a concern for users'

rights and an understanding of the fundamental importance of

removal on demand. Nonetheless, field conditions, perhaps

especially in the Third World, make it difficult to assure

removal on demand. How can family planning professionals and

consumer advocates do more public education about the risks,

the benefits, and the individual's right to insertion or

removal, for this and other provider-dependent methods? What

steps could women's health advocates take to assure

appropriate national level policies and administrative

directives about users' rights? How best can donors,

researchers, and service providers help protect consumers?

IUDs, another provider-dependent method, have been a

popular reversible method of contraception worldwide. In the

last year, US pharmaceutical companies have withdrawn from

the US IUD market, not for safety reasons, but because they

cannot get liability insurance. However, FDA approval still

exists. IUDs themselves have been controversial with some

groups because the recommended conditions for service

delivery, including consumer information, are not always met.

How can service delivery systems be strengthened to protect

against risks such as perforation and infection, especially

in settings where sexually transmitted diseases are

prevalent?

Programs for commercial and community based
distribution of contraceptives are especially
appropriate for barrier methods such as the condom
and sponge. They increase users' access and
freedom to use or not, and often decrease costs.
They do not in their current form, however,
provide sufficient information about
contraindications and management of side effects
for such methods as oral contraceptives. Nor do
they usually link users to medical services.

While this concern was less fully discussed, it is the

other side of the provider-dependence coin. These systems

increase contraceptive availability, but at what risks to

users? Can innovative means be devised to minimize risks,

and can those that do exist, like pill package inserts, be

more systematically promoted and used? What can be done to

ensure that illiterate women have full information?

Can practical systems of research/industry/
provider accountability be designed?

Such systems would encourage more care to be taken in

screening women for contraindications, and in providing full

information and improved follow-up, especially for women who

are involved in clinical trials of new methods. Stronger

means need to be found to supply feedback from the public to

providers and researchers both before and when new

contraceptives are marketed. Registries for users'

complaints about service delivery, as well as about the

experience of side effects, could be maintained by women's

health advocates, by the population field, or both.

To a great extent, researchers do the work for
which they can get funding. Both women's health
advocates and researchers need to work to
encourage broader funding guidelines and the
generation of resources for relatively neglected
methods, such as barrier methods, and for better
service delivery mechanisms.

For example, women's health advocates and researchers

both may contribute to development of strategies to solve, or

at least reduce, the liability problem. They need to let the

pharmaceutical industry know that there is substantial demand

for new and improved methods, and to contribute their views

on the appropriate grounds for consumer complaints. Both the

population establishment and the women's health movement need

to give attention to the restrictions on abortion-related

work. Can these efforts be made in ways that also promote

funding for improved delivery systems and general health

services for women?

QUALITY OF CARE FOR THIRD WORLD
FAMILY PLANNING CLIENTS

The second day began with presentations by four

panelists engaged in reproductive health services in the

Third World: Dr. Rani Bang, a medical doctor working through

a private agency with government health clinics in India; Ms.

Sonia Correa, a leader of the women's health movement in

Brazil; Ms. Sandra Kabir, Director of the Bangladesh Women's

Health Coalition; and Ms. Cecilia Ndeti, staff member of the

Family Planning International Assistance (FPIA) regional

program in sub-Saharan Africa. Their presentations were

supplemented by an overview paper by Ms. Debbie Rogow, who is

a women's health advocate with international experience in

family planning programs.

Panelists reviewed specific details of situations in

their countries with regard to patterns of fertility and

contraceptive use, the structure and quality of service

systems, crucial components of quality care from their

perspectives, and efforts needed to improve quality.

It was evident from the presentations and Ms. Rogow's

paper that no one definition of quality of care exists or is

likely to be feasible, given differences in resource bases,

cultural characteristics, etc. Nonetheless, some common

themes emerged. Women around the world are anxious, even

desperate, as indicated by high abortion rates, for

reproductive health services, despite the often poor quality

of those services. Recurrent concerns included generally

weak public health systems not designed to meet women's

reproductive health needs; covert and overt coercion in some

family planning programs (not just through payment schemes

but through acceptance "targets," refusal to remove IUDs,

policies that make abortion conditional on IUD or

sterilization acceptance, and the like). Attitudes and

policies of major donors and national governments are

additional problems. Some believe that high quality care is

"too expensive" for poor countries, and that available

resources should be concentrated on contraceptive

"acceptance" and on "more secure" methods, including

sterilization. Donor and government policies often result in

an inconsistent flow of contraceptives to service delivery

points, and other problems.

The participants envision many ways to improve quality

of services in which both women's health advocates and

population professionals could collaborate. These include:

o identifying and involving local women's groups in
the design and evaluation of family planning
programs;

o increasing funding for comprehensive reproductive
health programs, which requires considerable
political pressure;

o defining and implementing higher standards of care
in specific programs, not only clinic-based, but
"community-based distribution" (CBD) and commercial
marketing schemes;

o defining quality of care guidelines that can be
used for monitoring quality of care as well as for
funding decisions;

o revising staff training programs and reward systems
to emphasize quality of care;

o studying neglected problems, such as clandestine
induced abortion, STDs, infertility, and maternal
mortality;

o encouraging dialogues on quality of care among key
actors;

o redefining program output measures; in particular
developing means to measure user satisfaction and
the continuity of contraceptive use, not just
contraceptive acceptance or prevalence.

1. Points of Consensus on Quality of Care

No one definition or standard of quality for
family planning services exists or is likely to be
appropriate to all settings at all times, though
agreement may be reached on some minimum elements
in both the US and developing countries.

Such elements might include the following:

o full information about all contraceptives;

o availability of a range of contraceptives,
including barrier methods;

o a counselling process, including the option of
group discussion, that enables each woman to make a
choice suited to her circumstances and encourages

her to consider alternative methods, especially if
she is not comfortable with the one she first
chooses;

o improved follow up mechanisms, including a record-
keeping system that enables service providers to
follow their clients;

o respectful treatment, including privacy and
confidentiality, and respect for clients as active
decision makers, not simply passive "acceptors" of
a contraceptive;

o adequate physical facilities;

o attention to management of services to reflect
concern for the user;

o selective provision of other health services to
meet women's reproductive health needs beyond
fertility control.

Providing even these minimum elements may only occur

gradually in many settings. Limited financial and

professional resources are an important obstacle. So also

are strongly held views of major actors (policy makers,

medical doctors, donors, and others) who may not yet

recognize reproductive health as a goal, but emphasize

narrower objectives of population control or child health.

More attention needs to be given to men's and
women's attitudes about sex, sexuality, gender
relations, and sexism. All of these affect and
are affected by women's reproductive choices and
services they have access to.

Reproductive health care entails much more than
contraception. A range of approaches must be
considered in developing strategies for
providing this care.

Most participants argued strongly for integrated health

and family planning services designed to meet women's

multiple needs (including their children's health), to screen

for contraindications to certain contraceptives, and to

manage side effects, should they occur. Health

infrastructure is, however, generally poor in the Third World

and certainly does not give priority to reproductive health

problems. A frequent dilemma, therefore, is what

contraceptives to make available, and to which women, in

settings where health back-up is weak (see Appendix IV).

In these settings, the accountability of service
providers to their clients is weak and must be
strengthened.

In general, Third World service programs are primarily

accountable to their governments and/or to the Western donors

who fund them. They often have demographic, rather than

service priorities. In very few countries are there yet

consumer advocates, feminist organizations, or others who

seek to protect the rights and well-being of women who use

contraceptives.

The donors and national governments need education
on all these points to persuade them to reallocate
and better utilize their resources on women's
behalf.

In general, too few resources have been allocated for

expansion of the number of contraceptive methods available,

especially barrier methods; training for improved quality of

care; development of staff supervision and motivation

strategies to improve the standard of care; medical back-up

and surveillance; or counselling and information materials

for clients. Moreover, donor procedures often mitigate

against improved or even constant quality of care. For

example: commodity purchasing guidelines can result in sudden

changes in the types of oral contraceptives that are

available; a donor may provide equipment and buildings, but

not staff salaries and commodities; and so on. Donor

coordination and collaboration, with the involvement of

women's health advocates, is much needed.

Gynecological infections, including sexually
transmitted diseases and pelvic inflammatory
disease, are given low priority. It is very
important to increase attention to them.

Little is known about the epidemiology of infections, or

feasible means to diagnose and treat them, in most Third

World circumstances. Nonetheless, much could be done to pro-

mote barrier methods as a preventive measure, and to improve

screening and treatment, especially for women who chose IUDs.

Similarly, other gynecological problems, such as infertility

and those due to pregnancy and childbirth, receive little

attention in the international family planning field.

Women's health advocates have been awkwardly cast
as "nay-sayers" for responding to the apparent
absence of sustained provider and donor interest
in broader approaches to reproductive health care,
and means to improve quality of care.
Collaboration is needed.

Specific means to improve quality, and to assess the

costs of doing so, need to be developed. This may best be

done through increased cooperation between women's health

advocates and all levels of the population field (policy,

research, and service). Critics of service quality need to

be constructive, i.e., propose solutions and have access to

policy makers and service providers, if they are to be

effective. Furthermore, women's health advocates need to

guard against the manipulation of their concerns by those who

would dismantle international assistance for family planning

services.

Meetings like this, as well as other kinds of
contacts between women's health advocates and
those concerned with international family
planning, should be fostered.

At least four key issues require further discussion and

strategic planning:

o the role of service delivery systems, both medical
and nonmedical, in conditioning the risks and
benefits of provider-dependent methods;

o consumer information about contraceptives
distributed commercially;

o more systematic incorporation of users' views in
the development of contraceptive research
priorities;

o the development of appropriate US insurance
liability policies concerning contraceptive
development, manufacturing, and distribution.

2. Issues for Further Discussion and Definition of Desirable
Actions on Quality of Care

Participants generally agreed that much is to be gained

from continued dialogue and other kinds of interaction and

collaboration. It is in everyone's best interests to define

both practical short-term measures -- such as dialogues,

symposia or consultations -- as well as longer-term

strategies and mutually compatible public postures.

Mechanisms still need to be designed and various substantive

and political issues need to be resolved. Both the

population field and the women's health movement are already

heavily committed, and they may have to shift their

priorities, staff assignments, and budgets to meet these

challenges.

As no universal standard of quality of care is likely to

be appropriate, sensitivity to local circumstances should be

emphasized. Care should be exercised to assess women's needs

and perspectives and to involve women's health advocates from

the country.

THE NEXT STEPS

The consensus that women everywhere need more and better

contraceptive choices, safe abortion services, and broader

reproductive health care, provides a firm basis for

continuing dialogue and collaboration. Some "inside" and

"outside" the population field are already finding ways to

pursue mutual objectives and to collaborate on research,

policy design, and program implementation. With more such

collaboration and continuing dialogue, a more formal

coalition may develop.

As strong forces currently seek to curtail contraceptive

development and family planning programs (including safe

abortion) worldwide, both the population field and women's

health advocates will gain by using each group's political

power and practical experience for the greater good.

Although differences are likely to remain between and within

the two groups, sufficient common ground -- and a clear

humanitarian need -- exists for alliances to be built.

We must draw on our best substantive and political

expertise, proceed deliberately, and be prepared for a long

haul.

APPENDIX I

AGENDA

The Contraceptive Development Process and Quality of Care

in Reproductive Health Services

A Meeting Held in New York City

October 8-9, 1986

AGENDA: DAY ONE

Date:

Place:

Topic of the Day:

Time

10:00

10:30 11:00

11:00 11:30

11:30 12:30

October 8, 1986

International Women's Health Coalition in
the Salon -- 684 Park Avenue
New York, New York 10021

Resources for and Priorities in
Contraceptive Development

Subject

Refeshments/Welcome: Joan Dunlop
(International Women's Health Coalition)
and Judith Bruce (The Population
Council).

Linda Atkinson will present highlights of
her background paper on two decades of
contraceptive research.

Highlights of two reports on a) user
research on NORPLANT introduction, and
b) research and funding for RU 486.

Discussion/Question and Answer
Chair: Judith Bruce

What have been the costs, time, and
regulatory reviews required in
developing contraceptives?

Are there changes in features of the
contraceptive development process
that would reduce its cost and also
the time entailed in developing new
contraceptives?

What are the differential roles of
the public and private sectors, and
how do liability and profitability
affect their research processes?

What resource levels need to be
reached and issues faced in the
future if significant new
contraceptives are to be developed
for the next generation of women?

DAY ONE cont.

12:30 1:30

1:30 2:00

2:00 4:00

Date:

Place:

Topic of the Day:

Time

9:00 9:30

9:30 10:00

Lunch

Al Siemens (Family Health International)
will discuss prospects for developing new
barrier contraceptives.

Discussion/Question and Answer
Chair: Judy Norsigian (Boston Women's
Health Book Collective).

What are the contraceptive
development priorities of the
women's health care movement?

What forums and institutions need to
be influenced if elements of a
woman's health care agenda are to be
incorporated in the contraceptive
development process of the future?

DAY TWO

October 9, 1986

The Population Council in the John D.
Rockefeller 3rd Room
One Dag Hammarskjold Plaza
New York, New York 10017

Quality of Care for Family Planning
Clients in the Third World

Subject

Welcome/Introduction: Judy Norsigian and
Norma Swenson (Boston Women's Health
Book Collective).

Debbie Rogow will present highlights of
her paper, which seeks to define the
issue of quality of care for women in the
Third World.

DAY TWO, cont.

10:00 12:00

12:00 1:00

1:00 2:30

2:30 3:00

Panel of international guests will
discuss the quality of care issues from
their national perspectives.
Chair: Debbie Rogow

Lunch

Strategies for improving the quality of
services in Third World countries. What
can US organizations do?
Chair: Judith Helzner (International
Women's Health Coalition).

Summary and closing
Chair: Joan Dunlop

S Group evaluation

S Next steps

Closing remarks

APPENDIX II

TWO DECADES OF CONTRACEPTIVE RESEARCH:

PROSPECTS FOR THE 21ST CENTURY

by

Linda E. Atkinson, Ph.D.

Prepared for

the

International Women's Health Coalition

and

The Population Council

September 1986
(Revised October 1986)

In 1966, women and men could control their fertility

with a variety of contraceptive methods. Those were:

diaphragms; spermicides, including foams, gels,

suppositories, and creams; tubal sterilization; intrauterine

devices (IUDs) like the Lippes loop; condoms; vasectomy; oral

contraceptives (OCs); abstinence and (illegal and often

unsafe) abortion. Twenty years later, in the United States,

women and men can control their fertility with diaphragms,

spermicides, tubal sterilization, condoms, vasectomy, oral

contraceptives, the sponge, abstinence and legal abortion --

in short the same number of options, minus the IUD still

exist.

What has happened in the intervening twenty years that

has produced this unremarkable picture? Did research on new

contraceptive methods grind to a halt after the "success" of

the pills? Quite the opposite, contraceptive research became

a publicly acceptable endeavor, gaining government support as

well as funding from the private and industrial sectors. In

addition, the health risks that became apparent with oral

contraceptives gave incentive to providing alternatives for

women (and later men) who desired to control their fertility.

Work on new birth control methods by the pharmaceutical

industry, for example, has resulted in major improvements in

the dosage forms of oral contraceptives. Pills now have one

tenth the amount of steroid contained in pills of 20 years

ago, yet high contraceptive effectiveness is maintained.

This lower dosage has not eliminated all complications, but

the side effects appear in fewer users. Improved surgical

techniques for tubal sterilization such as mini-laparotomy

and laparoscopy have contributed to the safety and

convenience of this operation, which is the most prevalent

form of fertility control in the United States and in many

developing countries.

The Contraceptive Leads

Dozens of potential methods, from novel birth control

vaccines and improved spermicidal suppositories to reversible

methods for men, have been explored during the past twenty

years. These are listed in Table 1. From the variety of

leads pursued, several methods have become available or are

now in advanced stages (Phase III clinical testing) of

development. These are the contraceptive sponge, the

cervical cap, copper-bearing IUDs, the Progestasert IUD, the

levonorgestrel IUD, subdermal implants (NORPLANT), improved

injectables, and vaginal rings.

Research has emphasized the development of new delivery

systems for progestins -- synthetic steroids that resemble

progesterone rather than estrogen or testosterone in their

activity. These steroids are capable of preventing ovulation

when given continuously in low doses. It is believed that

without the estrogen component the serious cardiovascular

complications of combined oral contraceptives will be

virtually eliminated. Clinical studies so far would appear

to confirm this. The progestin-only approach was first tried

with mini-pills. This proved unsatisfactory because of

higher pregnancy rates and more irregular menstrual spotting

and bleeding. The latter problem exists with all progestin-

only methods but is generally thought not to pose a health

risk because the amount of blood lost is smaller than that in

a normal menstrual flow.

The NORPLANT subdermal implants contain the progestin,

levonorgestrel, in small silastic reservoirs that deliver

about 30 micrograms of the steroid per 24 hours. This dose

level has been highly effective without producing many of the

side effects associated with OCs. A one-centimeter incision

is made in the skin of the upper arm with local anesthesia

for insertion or removal of the implants. The implants are

highly effective for as long as five years. However,

NORPLANT can be removed at any time during the five-year

period if the method proves unsatisfactory or pregnancy is

desired. NORPLANT is now being introduced into countries

in Europe, Latin America, Asia, and Africa after regulatory

approval was obtained in Finland and Sweden. It is expected

that the US Food and Drug Administration (FDA) will approve

NORPLANT during the coming year.

Another implant system, the single capsule, CapronorTM ,

is designed to release about 30 micrograms of levonorgestrel

for 18 24 months, after which the implant biodegrades into

water and carbon dioxide, thus eliminating the need for

surgical removal. Research on this product is in the middle

of clinical testing and will be available in several years,

if the testing goes well. Clinical tests have been completed

on a vaginal ring that also releases levonorgestrel. The

device is similar in shape to a diaphragm rim, but is softer

and smaller and is worn continuously. It is less efficacious

than implants but has the advantage of easier removal and

discontinuation. The vaginal ring may be available in Europe

and some developing countries in a year or two. The most

advanced injectables are reformulations of Depo-Provera (in a

lower dose) used alone or in combination with an estrogen for

a monthly regimen. The modified injectables may be available

in the next year or two. Postcoital pills used for

unprotected intercourse at midcycle, are prescribed only

under medical supervision. Both estrogens and high doses of

combined OCs have been used for this purpose. The estrogens

tend to create more gastro-intestinal side effects than the

estrogen/progestin combination. Neither are to be taken

routinely because of the high dose. Transcutaneous patches

for delivery of contraceptive steroids are still in the early

stages of development. Nasal spray delivery of contraceptive

steroids has not proven reliable.

In parallel with the development of safer progestin

contraceptives, researchers have tried to produce better

nonsteroidal methods. Those approaches have included

research on intrauterine devices, predominantly the copper-

bearing models which were eventually refined to be more

effective, and with fewer expulsion problems than the Lippes

Loop. Work has continued on designing IUDs to ameliorate

problems such as heavy menses and the high expulsion rates of

post-partum-inserted IUDs. An IUD that releases about 20

micrograms of levonorgestrel per day has been shown to

substantially reduce the amount of blood loss in wearers

compared to other IUDs. The IUD is long-lasting and highly

effective also. Post-partum IUDs have undergone several

designs, but retention has been found to result from the

skill of the person inserting the device and its correct

placement, rather than the design per se. Intracervical

devices have been proposed to lessen the chance of

intrauterine infection and increase ease of insertion of the

device. Most studies show, however, that the device has a

high spontaneous expulsion rate and present designs will not

have the advantages originally sought.

Research has sought to develop safe and effective early

abortifacients that could be self-administered when a woman's

period was late. One group of substances, prostaglandins,

looked very promising in the early stages of research, and

millions of dollars have been used for prostaglandin research

over the last 15 years. Early clinical trials showed that

doses resulting in 90 percent or more complete abortions were

accompanied by severe vomiting, diarrhea and uterine

cramping. Subsequently, the prostaglandin molecule has been

modified to retain activity with oral administration and to

reduce gastrointestinal side effects. Recent studies

indicate that complete abortions can be obtained in 95

percent of volunteers with a two-tablet regimen. However,

discomfort from gastrointestinal side effects still persists.

After many years of searching, a new group of compounds

that show promise as menses inducers has been discovered. It

is hoped that these anti-progestins could be taken once a

month by a woman to induce menstruation whether she is

pregnant or not. The most widely studied, RU 486, blocks the

interaction of progesterone with its receptor in the

endometrial cell of the uterus. This action prevents the

cell growth and secretion that is normally induced by

progesterone and is required for implantation of the

fertilized ovum and subsequent successful pregnancy. Initial

clinical trials have attempted to define the appropriate dose

and timing to bring about complete interruption of early

pregnancy and to observe possible side effects. While side

effects are minimal, there appears to be a 10 percent failure

to induce complete abortion. Because of this need for

follow-up with conventional abortion in some cases, RU 486

will require strict medical supervision. This method may be

marketed in Europe next year.

The quest for a nonsteroidal inhibitor of ovulation has

centered on using modifications (analogs) of the brain

hormone, LHRH luteinizingg hormone releasing hormone). The

natural peptide, composed of ten amino acids, was identified

by 1970. By the late 1970s it had been demonstrated that

ovulation could be reliably but reversibly stopped if

analogs of the peptide were taken (by nasal spray) daily.

However, the original optimism about lack of important side

effects was shattered as careful studies raised questions

about estrogen deficiency and its manifestation in

osteoporosis by the long-term use of the peptide. At the

present, the use of agonist (enhancing activity) analogs is

on hold while research on the osteoporosis issue is carefully

assessed. Meanwhile, new antagonist (blocking activity)

analogs that could be taken intermittently to avoid estrogen

suppression have become available. These antagonists,

however, had other side effects that required modification of

the peptide. A satisfactory method of administration of the

analogs must be found because the analogs are not active when

taken by mouth. However, it is believed by many scientists

that these issues can be resolved and the lead is worth

pursuing.

There are some 5000 plant products that are alleged to

be used by practitioners of indigenous medicine for both male

and female fertility regulation. While indigenous plants and

herbal medicines should provide clues for new methods, this

approach faces as long a development process to establish

efficacy and safety as any other substance. A long-term

project has been established by the World Health Organization

to identify some 500 plants, attempt to extract the active

componentss, and test for antifertility activity in animals.

To date, few active substances have been confirmed that also

do not have unacceptable toxicity problems.

Almost a decade of research has been done on nonsurgical

methods of tubal closure based on the delivery of sclerosing

agents to the fallopian tube via the uterus. The most

extensive studies have utilized methylcyanoacrylate (MCA) as

a tissue adhesive. Results of clinical trials with MCA

showed that about 90 percent of women had closed tubes after

two MCA applications a month apart. Follow-up of women with

apparent bilateral closure of their tubes showed a cumulative

pregnancy rate of 3.5 per 100 women at 24 months and 4.3 per

100 at 36 months after the procedure -- far higher rates than

with conventional laparoscopic or minilap sterilization.

A method for use by a woman to predict her fertile

period with some accuracy and to choose whether to abstain

from intercourse or use a barrier method is attractive

because the procedure should be less medically oriented, and

nonintrusive. The problem so far has been lack of reliably

predictive biological markers -- many indicators are

sensitive only to changes occurring 24 hours before or soon

after ovulation. However, to prevent fertilization,

abstention/protection must occur several days before

ovulation because sperm are perfectly capable of waiting

several days in the fallopian tube for an egg to appear.

Current investigation of biochemical markers to predict

ovulation includes both an evaluation of the accuracy of

urinary glucuronides of estrogen and a simple color test to

indicate the specific activity of a peroxidase which appears

in cervical mucus and vaginal secretions at midcycle.

Calendar and temperature methods are also undergoing

reevaluation as markers of the fertile period.

The concept of a vaccine for fertility control has held

great attraction for family planning programs because of the

perceived high acceptability of vaccines generally. The

potential advantage of the immunological approach is that it

is likely to specifically interfere with fertilization or

pregnancy. Therefore, irregular menstruation and side

effects involving the liver and endocrine system are not

expected to occur. Vaccines to prevent pregnancy have been

under development for about ten years. During much of this

time, research addressed safety concerns and new vaccine

adjuvants were developed. Two candidate vaccines using

portions of the pregnancy hormone, human chorionic

gonadotropin (hCG) will begin clinical trials soon.

Years of effort to provide more contraceptive choice

for men have not yet achieved success. Research has

emphasized drugs that suppress the production of sperm, and

chemical or mechanical vasectomy. Suppression of

spermatogenesis is a difficult biological problem:

inhibition of sperm production requires long-term treatment

(two months) before sperm are absent from the ejaculate, and

subsequent complete suppression of sperm production is

inconstant. Drugs that induce azoospermia indirectly by

lowering testosterone synthesis will also diminish libido and

potency. In addition, the required doses (10 50 times the

pill) are so large that the metabolic load is high and toxic

side effects are likely. The recent development of new

drugs, delivery systems, and potent androgens for replacement

therapy, however, has opened new possibilities in the control

of male fertility. Further, substantially more research has

been focused on the male reproductive system in the past ten

years. Thus, for example, new knowledge about the control of

sperm maturation in the epididymis is increasing and may lead

to new ideas for fertility control.

Approaches to male contraception utilizing steroids in

oral preparations, injectables, and implants have not been

successful, as noted above. Anonsteroidal approach using

the analogs of the brain hormone, LHRH, to produce

azoospermia has been frustrated by similar problems: daily

injections of analogs have reduced libido unacceptably

(because of low testosterone), while not consistently

producing zero sperm counts. The addition of testosterone,

while improving libido, appears to restart sperm production.

Thus, this hormonal replacement has to be carefully

controlled. Newer, more potent analogs of LHRH are

anticipated to solve some of these problems when used in

conjunction with a more sophisticated testosterone

replacement system. The new analogs will be in clinical

trials soon.

Chinese scientists first reported the use of gossypol, a

component of cottonseed oil, as a male contraceptive several

years ago. Work to purify gossypol, to synthesize chemical

analogs, and to understand its mechanism of action has been

in progress. Although clinical trials in China showed that

gossypol was an effective contraceptive and could induce

azoospermia without reducing libido or potency, there are

some safety concerns with the method. One concern is that

fertility is slow to return -- 20 percent of men are still

infertile 12 months after treatment is stopped. Another is

that gossypol lowers serum potassium levels in some men and

may have deleterious effects on muscle, heart, and kidney

function.

At least a half dozen classes of chemicals have been

tested as systematic contraceptive agents and have shown

varying ability to disrupt sperm maturation and decrease

sperm motility in animals. However, all drugs examined so

far have been characterized by unacceptable levels of

toxicity in acute tests.

Attempts over the past decade to design a reversible

vasectomy with clips, plugs, and valves have been notably

unsuccessful. Such attempts have resulted either in not

adequately blocking the passage of sperm through the vas or

causing considerable necrosis of the vas so that future

fertility is compromised. However, recent studies of a new

device suggest that reversible blockage of sperm movement

through the vas may be possible. A device, the Shug, is made

of two silicone plugs held together by a nylon suture. They

are placed within the vas, pointing in opposite directions,

through a puncture made by an injection needle. Experiments

in primates with the device in place have demonstrated

success in blocking sperm transport through the vas. When

the device was removed, sperm were once again found in the

ejaculate. Clinical trials are planned as soon as an

application to the Food and Drug Administration can be

submitted.

The Research Climate

The past twenty years of research have been shaped by

considerations that were entirely different from those that

had preceded them. These considerations have been

regulatory, economic, and political. The first and most

widely influential has been the changes in the Food, Drug and

Cosmetic Act that were legislated in 1962 after the notorious

thalidomide tragedy occurred. Although these revisions were

enacted after the first oral contraceptive products were

introduced (1960), later pill combinations or OCs containing

new estrogens or progestins were subject to the regulations.

In addition, as concerns grew about the side effects and

safety of OCs, special regulations were evolved for

establishing the safety of steroid-based contraceptives.

Those requirements, shown in Table 2, are much more extensive

than for drugs used to treat illness. Specifically, longer

tests in more animal species are required before the drug can

be tried in humans even in a limited fashion, and long-term

ongoing studies (seven years in dogs and subhuman primates)

must be under way before the last phase of clinical testing

is allowed in humans. Only if the FDA is satisfied that

safety and efficacy have been demonstrated in the required

clinical trials and animal tests, and that the proposed

labeling of the substance reflects its uses, dangers, and

possible side effects, is pre-marketing approval given.

In 1976, new FDA regulations went into effect concerning

devices used inside the body. Before this time, regulatory

laws did not apply to devices, including IUDs such as the

Dalkon Shield, at all. Cervical caps have been the most

recently regulated contraceptive devices under this law. (The

early copper IUDs were considered to be new drugs since they

had an "active" system, copper, on an inert plastic carrier.)

Partly because of the new costs of fulfilling FDA

requirements, economics have become a major determinant in

starting or continuing research for any new drug or device.

It has been estimated that if a research and development

effort starts with 1000 possible chemicals directed at a

specific therapy, only 10 of them will prove efficacious and

have acceptable toxicity profiles in animal screening. Of

these 10 that may be entered into early clinical trials, only

one will be safe and effective enough to obtain FDA approval

and be tried in the marketplace -- so the economic risk of

research is high.

If nonreproductive drug therapies have become more

expensive to develop, contraceptives increased even more

because of the extra time and testing requirements involved.

A new contraceptive lead may cost the pharmaceutical industry

upwards of $40 $70 million to develop from the drawing

board. While these costs were shared across all of the

pharmaceutical industry, other considerations have tempered

expansive research and development in many companies. After

the highly popular OCs had gained a large market, some drug

companies were reluctant to spend research dollars on methods

that would displace or compete with their highly profitable

OCs. However, other pharmaceutical firms saw opportunities

for new products, and during the 1970s private industry

supported a large portion of research and development of new

birth control methods.

Political pressures have had both positive and negative

effects on the research environment for contraceptives. For

example, activist groups calling for more research on barrier

methods and male methods have gotten a response from research

organizations and industry. Action by consumer groups

against pharmaceutical firms was able to remove products from

the marketplace or prevent their entrance into the market,

but it also deterred those firms and others from further

involvement in innovative research. The absence of clear and

vocal support for research on new fertility control methods

has been discouraging to both private and public sector

organizations, particularly when anti-family planning groups

have been so evident.

The Research Organizations

During the 1960s virtually all contraceptive research

and development was done by pharmaceutical firms in the

United States and Europe. The last two decades have been

characterized by the emergence of publicly supported research

and development organizations as important players in the

work on new contraceptive methods. By the early 1970s,

family planning leaders concluded that OCs, the IUD, and

traditional methods were not going to solve the birth control

needs of developing countries, given the differences in

cultural perceptions of contraception and low levels of

health care infrastructure. It was further believed that the

pharmaceutical industry would not be interested in methods

suited to the perceived needs of developing countries --

methods that in addition to being safe and reliably

effective, are easy to use, long-lasting, and do not require

highly trained medical personnel for delivery. Thus

contraceptive research and development efforts were begun by

publicly supported agencies such as the International

Committee for Contraception Research (ICCR) of the Population

Council, the Programme of Research, Development and Research

Training in Human Reproduction (HRP) of the World Health

Organization, Family Health International (FHI) -- originally

the International Fertility Research Program, and the Program

for Applied Research on Fertility Regulation (PARFR). In

addition to these groups, whose mandate was to develop

improved methods for the nonindustrial world, the

Contraceptive Development Branch of the National Institute of

Child Health and Human Development's Center for Population

Research was established to support research on methods

meeting the needs of American couples. (These aims are not

mutually exclusive but are useful political distinctions.) A

few years later, the Program for the Introduction and

Adaptation of Contraceptive Technology (PIACT) was launched

as a bridging organization to adapt existing and new

contraceptive methods for developing countries through

assistance with informational materials, packaging, local

manufacture and quality control. In 1980 the Indian Council

of Medical Research established a National Programme for

Research in Human Reproduction which supports basic and

clinical research on new methods of fertility control. The

International Organization for Chemists in Development was

founded in 1981 to involve chemists and biologists from

developing countries in the search for fertility regulating

methods for their own regions. A more detailed description

of each organization, its goals and funding sources is

provided in Attachment A.

Each of these organizations has its unique set of donor

pressures and constraints, priority-setting systems and

clientele to which it must be responsive. Major donors --

mainly governments -- have their own agendas, and these are

usually determined by short-term political considerations,

such as the ban on abortifacient research by agencies

receiving US government funds. In all of the major donor

countries -- primarily the US, Canada, Western Europe, and

Australia -- research on fertility regulation is not of high

priority even though existing methods are inadequate or have

safety concerns. Further, support for research on methods

for developing countries is subject to the ups and downs of

interest in foreign aid and population assistance. As a

consequence, contributions to publicly supported agencies

fluctuate greatly from year to year, sometimes decreasing

abruptly, thus making sensible planning extremely difficult.

Within each agency, research directions and priority

setting are determined by a number of variables. All the

organizations receive input from their technical and policy

advisory committees, donor representatives, their own

scientists and consultants, and the field in general

regarding needed birth control methods. These inputs are

quite varied and represent a wide range of viewpoints. The

agencies do look for areas of need or underserved groups,

such as methods for men, methods for nursing women, improved

barriers and spermicides, etc. The next level of decision

making considers what will be scientifically and technically

feasible. The third level of research planning incorporates

into its decisions expected funding levels, commitments to

ongoing work, and projections as to the duration of the

project and cost of preclinical or clinical work of any new

research. Thus greater weight is given to some leads than to

others. At present, the established input from a consumer

viewpoint originates primarily from a client through clinic

personnel.

Research Funding

Trends in worldwide expenditures in the reproductive

sciences and contraceptive development have been tracked by

the Ford Foundation and more recently by the Alan Guttmacher

Institute. (Figures and trends quoted below are obtained

from References 1 and 2.) Funding of contraceptive research

and development in the 1960s was largely from private

foundations, individuals, and industry. During the 1970s,

governments played an increasingly larger role in this area,

particularly in support of basic research in reproduction.

Expenditures in selected years over the last two decades are

shown in Table 3. Contraceptive research dollars increased

over this time period from $11 million to $59 million. The

greatest increment occurred in the 1970s, reflecting the

increasing contributions of governments. However, when

inflation is taken into account, it can be observed that the

actual research buying power has remained stable at about $20

$22 million for the last ten years after peaking in 1973

(constant dollars). About half this amount has been expended

for research on the long-term safety of existing

contraceptives. Results from safety research have

significantly influenced the direction of research done on

new methods. In addition, approximately one and one half

times the amount spent on contraceptive research has been

spent on work in the basic reproductive sciences.

Of the total worldwide funds granted for contraceptive

research and development, fundamental research and training

in the reproductive sciences, and long-term safety

evaluation, 70 to 84 percent came from the United States.

The US government spent or contributed about 60 percent of

the funds in recent years, up from 25 percent of the total in

1970. Foundations, which were major donors in the early

1970s, are now a source of only four percent of the worldwide

total. The American and European pharmaceutical industry

accounted for approximately 10 to 20 percent of expenditure

over the last 20 years.

Funds originating from other developed countries

represented only 14 percent of all expenditures, down from

about 30 percent a decade earlier. Developing countries have

contributed two percent to the worldwide effort over the last

two decades. Thus the overall trend in funding of

contraceptive research and allied activities in safety

evaluation and reproduction research shows a rapid increase

during the early 1970s with slower gains during the 1980s.

The overall effect of inflation during this period has been

to stabilize or slightly decrease available funds when

analyzed in constant 1970 dollars. During these two decades,

the pharmaceutical industry and foundations played a

proportionately declining role as government contributions

increased.

Between 1980 and 1983, the seven publicly supported

contraceptive research organizations mentioned above were

spending about 40 percent of the available funds. Industry

represented about 35 percent of research activity, and

universities and other research organizations about 25

percent of the total (see Table 4). It can be noted that

during this period, industry's expenditures increased

markedly -- from $15 million to $27 million -- while budgets

of the nonprofit organizations remained steady or declined.

Since 1983, there has been a notable decline in US

pharmaceutical contraceptive research activity and

subsequently, it is supposed, a decrease in research

expenditures.

The percentage distribution of contraceptive research

and development funds by method category during the period

1980-1983 is shown in Table 5. Not surprisingly, over 25

percent of expenditures were directed to research on improved

OCs and new delivery systems for progestins. Postovulatory

methods, which include postcoital pills, abortifacients and

menses insurers, received increasing attention over this

period, becoming the single most important area by 1983. A

relatively small portion of funds could be categorized in

research on methods for men during this period. The biggest

research leads in this group were LHRH analogs and gossypol.

While virtually all organizations and some industrial firms

were actively involved in work on male methods, the low level

of funding probably indicates that only a few opportunities

exist now for exploitation because our knowledge of male

reproduction is minimal. Almost one third of the research

funding could not be attributed to any single method but

reflected large grants for multiple methods or synthesis of

compounds that could be used for both male and female

contraceptive leads.

And Into the 21st Century

The course of contraceptive research and development in

the near future has become difficult to predict because

recent events concerning product liability issues and the

anti-family planning political climate have drastically

changed the potential progress of research, who will be doing

it, where the research will be done, and how much it will

cost. The rising number of lawsuits in the United States

against manufacturers of virtually all contraceptive products

-- oral contraceptives, IUDs and spermicides -- and the A. H.

Robins bankruptcy filing because of lawsuits over the Dalkon

Shield device has completely changed the way pharmaceutical

firms, who traditionally were involved in contraceptive

research, view this area of investment. Because product

liability insurance is virtually impossible to obtain at any

cost, large companies are forced to self-insure. The

resulting costs have been passed on to the consumer in higher

purchase prices of OCs and other products. Within the last

year, Ortho Pharmaceutical Company stopped selling the Lippes

Loop because its profit margin would not support the costs of

pending litigation. G.D. Searle also has made a similar

decision regarding the Copper 7 and Tatum T IUDs -- not for

scientific reasons or because the products are defective --

but to protect the company against future lawsuits and the

attendant costs of litigation. Ortho, the largest

manufacturer of spermicides, faces these cost considerations

due to a recent $4.7 million judgment against their product.

The impact on the American people is threefold. First,

the number of contraceptive options has already been

significantly reduced and the potential for losing

spermicides and pills also exists. Second, industry now

views contraceptive research and development as a bad place

to put their investment dollars and will direct their

research activities into other therapeutic areas. Thus, the

field has lost a major participant in the development of new

and improved methods. The third effect, because product

liability insurance is not available, is to keep from the US

market any new methods that may be approved by the

FDA in the near future, such as the Copper T 380 IUD and

NORPLANT subdermal implants. A major advance in methods,

the menses inducer RU 486, will not be made available or even

tested in the United States, although it is expected to be

registered in European countries in the next year.

The impossibility of obtaining insurance has virtually

halted all clinical research on new methods of fertility

control in the United States by publicly supported

organizations such as the ICCR and FHI. CDB has waited three

years to find a university that will self-insure the Phase I

and Phase II testing of its CapronorTM implant. This means

that for the near future, while preclinical work --

laboratory experiments, dosage formulation and toxicology

testing -- can go forward, clinical testing will have to take

place outside the US. If the insurance problem is

alleviated, clinical trials will have to be repeated at a

later date in the US in order to obtain FDA approval of the

method.

In spite of these problems, research on promising new

methods for the 21st century will proceed. These will be

pregnancy vaccines, methods for lactating women, new

injectables, and the exploration of new opportunities to

interfere with male fertility. A large research project on a

series of potential spermicides has recently begun. In

addition, it may be expected that small start-up companies

will become involved in the development of new barrier

methods and spermicides as these methods will gain in

importance in the prevention of sexually transmitted diseases

(STDs), including auto-immune deficiency syndrome (AIDS).

The extent of progress will depend to a large degree on the

funding picture for publicly supported agencies. As pointed

out earlier, funding has stagnated, forcing research groups

to forego those leads in earlier stages of development in

favor of completing the most costly advanced leads. The Alan

Guttmacher survey reported that the principal public sector

groups estimate they need about a $23 million annual increase

over the next three years above their current annual level of

$30 million in order to optimally insure progress of methods

under development and to begin work on new contraceptive

leads.

REFERENCES

1. Atkinson, L., S.B. Schearer, O. Harkavy, and R. Lincoln:
"Prospects for Improved Contraception." Family
Planning Perspectives 12:173-192, 1980.

2. Atkinson, L., R. Lincoln, and J.D. Forrest: "Worldwide
Trends in Funding for Contraceptive Research and
Evaluation." Family Planning Perspectives 17:196-207,
1985.

3. Atkinson, L., R. Lincoln, and J.D. Forrest: "The Next
Contraceptive Revolution." Family Planning Perspec-
tives 18:19-26, 1986.

Table 1

TWO DECADES OF CONTRACEPTIVE RESEARCH--THE METHODS

Methods for Women

Barrier Methods
cervical caps
diaphragm with spermicide
improved suppository spermicides
new spermicide agents
reformulated spermicides
sponge with spermicide

Methods Using Steroids
improved oral contraceptives including:
reduced dosage, mini-pills, biphasic and
triphasic formulations
post-coital pills
subdermal implants
injectables
transcutaneous patches
intranasal sprays
vaginal rings

Other Systemic Methods
abortifacients
menses inducers
brain hormones for ovulation inhibition
plant products

Intrauterine Devices
copper-bearing
post-partum
medicated to reduce bleeding

Intracervical Devices

Improved Sterilization
reversible
nonsurgical
rings and clips for occlusion
mini-laparotomy
laparoscopy

Markers for identifying the fertile
part of the cycle

Pregnancy Vaccines

Methods for Men

Methods Using Steroids
oral contraceptives
injectables
implants

Other Systemic Methods
brain hormones for sperm suppression
gossypol
other antispermatogenic compounds
sperm motility inhibitors

Improved Sterilization
reversible vasectomy
nonsurgical vasectomy

Table 2

Preclinical Requirements
for Contraceptive Drugs

Contraceptives

Other Drugs

Prerequisites for:

Phase I

Phase II

Phase III

NDA

From: J. DI Raddo and W. Wardell Contraception 23:345,1981

Ninety-day studies in rats, dogs,
and monkeys must be completed Phase I studies can be initiated
prior to Phase I studies, which after 2-4 week studies in 2 animal
involve 10-20 individuals for up to species.
10 days.

One-year studies in rats, dogs, and
monkeys must be completed prior Phase II studies can be initiated
to Phase II studies, which involve after 90-day studies in 2 animal
approximately 50 women for 3 species.
menstrual cycles.

Two-year studies in rats, dogs, and
monkeys must be completed and
7-year dog and 10-year monkey
studies must be initiated before
Phase III testing may begin.

Chronic toxicity studies, including
Progress reports on long-term 1-year dog, 18-month mouse, and
studies in dogs and monkeys are 2-year rat studies, must be
required at the time of NDA completed by the time of NDA
submission. submission.

Table 3

TWO DECADES OF CONTRACEPTIVE RESEARCH--EXPENDITURES, 1965-1983

1965 1969 1973 1977 1981 1983

Current Dollars (000s) $10,950 16,364 30,767 31,416 50,677 56,897

Constant 1970 Dollars (000s) 13,509 17,368 26,451 20.108 21,638 22,174

Source: Atkinson, et al., (1980); Atkinson et al. (1985)

Table 4

EXPENDITURES FOR CONTRACEPTIVE RESEARCH BY ORGANIZATION, 1980-1983

Organization 1980 1981 1982 1983

Total* $52,812 $62,546 $66,482 $69,061

CDB 8,131 8,354 8,491 8,688
HRP 8,670 6,532 6,149 5,423
ICCR 2,716 2,988 3,580 3,934
FHI 2,774 3,051 2,176 2,665
PARFR 1,641 1,708 1,495 1,663
PIACT 428 2,350 4,200 780
ICMR 832 844 799 1,317
Private Industry 15,320 21,175 23,064 27,307
Other 12,302 15,543 16,528 17,284

Source: Atkinson, et al., (1985)
*These totals include as a part -of contraceptive research funds
allocated to fundamental mission-oriented research. The totals
therefore differ from the amounts in Table 3 which do not include
this component.

Table 5

PERCENTAGE DISTRIBUTION OF EXPENDITURES FOR CONTRACEPTIVE RESEARCH
BY TYPE OF METHOD, 1980-1983

Contraceptive Method 1980 1981 1982 1983

$52,812 $62,546 $66,482 $69,061

Oral contraceptives 10.2 11.4 11.0 9.9
Steroid injectables 1.4 2.0 1.2 2.8
Steroid implants 3.3 3.3 3.7 2.6
Vaginal rings 2.4 1.5 1.5 1.1
Other ovulation inhibitors 12.4 11.7 12.5 11.7
IUDs and ICDs 2.3 1.3 1.9 1.4
Postovulatory methods 10.2 12.1 14.9 18.0
Barriers and spermicides 4.8 6.1 4.3 3.3
'Tubal sterilization 1.8 0.5 0.5 0.2
Periodic abstinence 1.4 0.7 0.2 0.2
Vaccines 8.0 8.4 10.0 9.5
Male methods 11.3 10.4 7.1 7.2
Multiple (male and/or female) 30.4 30.6 31.3 32.3

Source: Atkinson, et al. (1985)

ATTACHMENT A

Descriptions of Organizations Active in
Contraceptive Research and Development

Contraceptive Development Branch (CDB) of the Center for
Population Research, National Institutes of Child Health and
Human Development

1985 Budget: $7.7 million, all of which is dedicated to
contraceptive research and development.

Source of Funds: Appropriations by the United States
Congress.

Mode of Operation: Contracts to US organizations and
industry.

Descriptions: The purpose of the Contraceptive Development
Branch program is to develop an array of improved methods of
fertility regulation that would be acceptable to the various
segments of the United States' population. This includes
methods for both men and women although research is not
conducted in the area of abortion. In the early phases of
the program, 1969-71, expenditures were related to the
support of mission-oriented research on various anatomical
structures and systems critical to the reproductive process.
Later, CDB support was expanded to incorporate drug synthesis
and testing, as well as device development, development of
new methods of drug administration and development and
testing of improved barrier methods. Under these areas leads
that are currently being tested in clinical trials are the
CapronorT implant, LHRH analogues for men and women, a
spermicide-containing diaphragm, an improved cervical cap and
long-acting injectable contraceptives. CDB also does not plan
to manufacture or introduce methods that are successful in
clinical trials but would hope that a transfer to industry
can be effected. CDB has collaborated on several leads with
the Special Programme in Human Reproduction of the World
Health Organization, the Indian Council of Medical Research,
and other collaborating programs, as well as industry.

Family Health International (FHI)

1985 Budget: $8,221,000, of which $1,415,000 will be spent
on the development and introduction of new methods such as
injectables, implants, nonsurgical sterilization and
spermicides.

Source of Funds: US Agency for International Development,
Foundations.

Description: Family Health International was founded in 1971
to evaluate new and improved contraceptive methods in field
trials throughout the developing world, and to provide
developing country health and family planning programs with
up-to-date and reliable information on contraceptive
effectiveness and side effects. Over the years, FHI's
program has evolved and now includes contraceptive
development activities, research on the health consequences
of contraceptive use, evaluation of health and family
planning services, and support for training and developing
world scientists and strengthening of biomedical research
institutions in the Third World. FHI has been involved in
the development of long-acting steroid methods in
collaboration with PARFR, The Population Council and HRP.
*****

International Committee for Contraception Research (ICCR),
The Population Council

1985 Budget: $5.0 million, all of which is expended for
contraceptive development. In 1984, an additional one
million dollars was spent on the introduction of
NORPLANT implants.

Source of Funds: Foundations, US Agency for International
Development, individual contributions.

Mode of Operation: Capacity for in-house animal studies and
drug formulation; consultants do clinical studies and confer
on strategy and tactics.

Description: Founded in 1971, The International Committee
for Contraception Research of The Population Council seeks to
identify, develop, and evaluate promising leads for new
contraceptives, especially those that will be useful in
developing countries. The program, initiated in 1971,

defines its mission as being that of carrying development
from the point that an approach appears likely to have
contraceptive utility through attaining regulatory approval
in the United States or another developed country. Making
the method effectively available requires a systematic
introduction effort. The leadership in the introduction of
the Copper T 380 and NORPLANT contraceptive implants has
been assumed by the International Programs Division of the
Population Council.

Methods developed by the ICCR include three intrauterine
devices and the subdermal implants that have been given the
trade name NORPLANT Methods in advanced stages of
clinical testing include an improved subdermal implant and a
levonorgestrel-releasing IUD. Other methods presently being
tested clinically include analogues of LHRH for inhibition of
ovulation in women and for inhibition of sperm production in
men, a progesterone-releasing ring for inhibition of
ovulation in lactating women (with HRP), an antiprogestin for
use as an abortifacient (with industry), and an additional
potential improvement in subdermal implants. Methods
undergoing preclinical evaluation include a pregnancy
vaccine, substances or devices for ovulation inhibition, and
two possible products for use in men. ICCR is collaborating
with industry, HRP, FHI and CDB and universities.
*****

International Organization for Chemical Sciences in
Development (IOCD)

1985 Budget: $227,000 for synthesis of new chemical entities
for fertility regulation.

Source of Funds: United Nations Fund for Population
Activities, Foundations, Mexican government.

Mode of Operation: Grants to universities for chemical
research.

Description: Begun in 1984, the IOCD Chemical Synthesis
Programme in the area of fertility regulation is focussing
its attention on aspects currently not investigated by most
other agencies and/or industry. Particular emphasis is being
placed on the synthesis of new agents potentially active in
the male. Three classes of chemicals to arrest sperm
production or otherwise interfere with fertilizing capacity
of the sperm are now being investigated. In addition, IOCD

supports a limited study of natural plant products to
elucidate their structure and evaluate their biological
effects. Seven chemical laboratories located in Brazil,
Egypt, France, Mexico, Venezuela, and the United States are
participating in the program. IOCD collaborates with the
Human Reproduction Programme of WHO, the International
Committee for Contraception Research of The Population
Council, and the Program for Applied Research in Fertility
Regulation, as well as industry.

*****

Program for Applied Research in Fertility Regulation (PARFR)

1985 Budget: $3,091,400, of which $2,437,322 is spent on
research and development activities.

Source of Funds: US Agency for International Development.

Mode of Operation: Grants to universities, research
institutes, and individuals as recommended by a scientific
advisory committee.

Description: PARFR, established in 1972, provides
scientific, technical, and financial assistance for applied
research projects aimed at developing safe, effective, and
acceptable methods of fertility regulation. PARFR's
objectives are to shorten the time between the evolution of a
new idea in fertility control and its active application in
the field, to strengthen applied contraceptive research
interests in foreign and US institutions, and to review and
disseminate the findings of applied research in fertility
regulation. Specific research areas which can be supported
include laboratory studies, animal studies, or human
investigations leading to the development of contraceptive
methods that inhibit the maturation processes of sperm or ova
either at the local or central level, interrupt the transport
of gametes, interfere with the process of fertilization, or
provide for long-acting sustained release of anti-fertility
agents.

Program for the Introduction and Adaptation
of Contraceptive Technology (PIACT)

1985 Budget: $3,000,000 for technical assistance and
technology transfer, support materials, research on quality
control and product standardization, and publications about
currently available methods. About 10 percent of budget for
activities related to introduction of NORPLANT and Copper T
IUDs.

Source of Funds: Foundations, United Nations Fund for
Population Activities, governments.

Mode of Operation: In-country technical assistance;
materials and quality control development by staff.

Description: Begun in 1976, PIACT has as its objective
improving the availability, effectiveness, safety, and
acceptance of contraceptive and reproductive health products
in developing countries. PIACT meets these objectives
through programs of technology transfer and technical
assistance, quality assurance, information, education and
communication, and production introduction and adaptation to
local conditions. While PIACT does not conduct research
aimed at developing new contraceptives, it does engage in
activities to improve the delivery, performance, and
acceptability of contraceptive methods in developing
countries, and works with public sector agencies and public
or private industries whose goals and objectives are
compatible with its own. Relevant PIACT activities come in
at appropriate stages during the contraceptive development
process. For example, PIACT has collaborated with The
Population Council on the development of specifications and
quality control standardization for its Copper T IUDs. Other
examples are a model training arm for implantable
contraceptives, introduction of the Copper T 380 IUD,
including information packages for distribution to donors,
clinicians, and family planning managers worldwide. PIACT
will participate in the introduction activities of the
NORPLANT and Copper T IUDs.

Special Programme of Research, Development, and Research
Training in Human Reproduction (HRP) of the World Health
Organization

1985 Budget: $14 million, of which $5.1 million represents
expenditures on the research and development of new
contraceptive methods.

Source of Funds: Developed and developing country
governments, United Nations Fund for Population Activities.

Mode of Operation: Technical staff and task forces manage
research and development projects through grants to
universities, research institutes, and industry.

Description: The HRP was developed in recognition of the
need for an international research effort in the field of
fertility regulation. The HRP was established in 1971 with
the aims of developing a variety of safe, acceptable and
effective methods for fertility regulation and of monitoring
the long-term safety and efficacy of existing methods as well
as the support of institutions capable of conducting such
work. Subsequently, the Programme embraced a broader range
of activities emphasizing more institution strengthening of
research capacities in individual countries and adding work
on the delivery and acceptability of various contraceptive
methods, as well as research on infertility.

HRP Task Forces have concentrated on long-acting
systemic methods, such as new injectables, vaginal rings,
implants, anti-fertility vaccines, male methods, post-
ovulatory methods, natural (nonmedical) regulation of
fertility, indigenous plants for fertility regulation, and
termination of pregnancy with prostaglandins. While new
methods were under development, the HRP has assisted its
collaborating centres with the clinical study of available
methods such as oral contraceptives, IUDs, and sterilization.
HRP is presently collaborating with CDB, ICCR, PARFR, FHI,
IOCD, PIACT, and industry.

APPENDIX III

Quality Care in International Family Planning:

A Feminist Contribution

by

Deborah Rogow, MPH

The author wishes to thank Judith Bruce, Joan Dunlop,
Adrienne Germain, Judith Helzner, Norma Swenson, and Alice
Wolfson for valuable comments offered on drafts of this
paper. Naturally, I take full responsibility for the
contents.

Prepared for

the

International Women's Health Coalition

and

The Population Council

September 1986
(Revised January 1987)

When former allies explore a rapprochement after years

of conflict, the dialogue is bound to be interesting. The

international population establishment and the US women's

health movement are talking.

As part of and in preparation for that dialogue, this

paper addresses the basis for the "old alliance," what

happened to it, and the issues for feminists to consider in

exploring a rapprochement now.

Brief Historical Overview

International population programs were initiated in the

late 1960s. At that time, control of world population growth

was "loosely" considered a liberal concept. The new

conservationist movement was advocating population control to

slow the drain of global resources. The emerging feminist

movement was articulating demands for birth control. And

there were major scientific breakthroughs in the availability

of new contraceptive methods. The international and domestic

family planning "movements" were twins, born out of a broad

coalition that included women and liberals.

During the 1970s, both domestic and international family

planning programs burgeoned and evolved. While domestic

programs generally enjoyed high levels of use and served as

models for primary care, many international programs had

limited success in terms of continued family planning use.

Although there clearly existed an unmet need among women

everywhere in the world, too many programs exerted more zeal

for gaining "acceptors" than for providing high quality care.

A feminist critique of the population movement soon

developed, which differentiated between birth control (the

right of a woman or couple to control their childbearing

based on individual choice) and population control (a state

policy aimed at controlling the childbearing of a population

and based on a demographic imperative). This critique led to

the splintering of the coalition that had originally helped

usher in the funds and popular support for family planning

and abortion.

While one political coalition collapsed, another was

born. The Reagan era has seen a huge right-wing effort to

eliminate all publicly funded family planning, both domestic

and international. This political effort has forced many

feminists to confront a series of questions: since there are

women throughout the world who do want to prevent pregnancy,

how do we respond to the right-wing attack on international

family planning? Doesn't it make sense to cooperate with

individuals within the international family planning

establishment who also seek to improve the quality of care in

international family planning? And if so, how do we define

and propose achieving this "quality"?

In March, 1985, the Population Council and the

International Women's Health Coalition jointly sponsored a

one-day meeting to update about 35 women's health activists

about recent contraceptive research activities. The meeting

provided participants an opportunity to learn about new

methods. A subtext for the day was that two groups (the

population establishment and the women's health movement)

with overlapping interests in family planning had much to

learn -- and possibly benefit -- from a dialogue.

This paper seeks to raise certain issues that will allow

feminists to enter that dialogue. It further argues in favor

of working cooperatively within the population establishment

as one way to have a real impact on the quality of care and

reproductive choices for women in developing countries.

The Critique of International Family Planning

While arguments have been made that all forms of

international aid subvert autonomously defined and managed

development and ultimately foster dependence,1 most feminist

opposition to international family planning programs has

stemmed from a concrete critique of the priorities and

quality of these programs.2 Population programs have had

the primary goal of lowering fertility rates rather than

meeting the needs of and empowering the women they are

supposed to serve.

There is considerable documentation of how this priority

has precluded quality care. Interestingly, much of the

recent documentation has been by individuals working within

international family planning organizations. While I do not

intend to provide a comprehensive review of the problems in

international family planning services, some of this

documentation bears mention as testament to the weight of the

critique.

First are problems with the contraceptive methods

themselves: many programs offer only one or two methods.

The methods offered are usually those that are considered

"effective" and require less "compliance" on the woman's part

(e.g., pills, Depo-Provera). This bias in what is available

persists despite the research showing that continuation rates

rise when a program begins to offer a greater number of

methods.3

Some poignant examples exist. In Mexico, the largest

national health system (Instituto Medico de Seguro Social)

adopted a policy several years ago that 90 percent of women

leaving the Seguro hospitals after delivery should have an

IUD inserted. A large family planning program in Thailand

reported up to 75 percent of their clients using their (i.e.,

the clinic's) "favored" method, Depo-Provera.5 Even a

"model" income-generation/family planning program in

Bangladesh reports from one zone that "those of my members

who can are all taking pills." 6

And the trend is not optimistic. In a recent

conversation with members of the Boston Women's Health Book

Collective, a high official of AID's Population Program

indicated that there is a trend among many national

governments toward more coercion.7

Women switch methods during their reproductive life

spans, and a greater number of available methods increases

the chance of finding a satisfactory method and allows for

switching where there is dissatisfaction. In the US, it is

typical for a woman to use three or four different methods

during her reproductive years. Such switching reflects a

failure in the method, not in the woman, as many family

planning programs would view it.

A related issue is that in many cases the methods most

available may not be acceptable from a health or personal

standpoint. Studies show that about half of women who state

they want no more children, yet are not using contraception,

are "disenchanted former users." 8

Feminists here and in other countries have raised

concerns about the acceptability of certain methods at all.

Depo-Provera is still considered a potential carcinogen and

is banned from the US market. Implant users requesting

removal of their method in the Third World may meet

resistance and refusal from doctors. Sterilizations that do

not involve thorough informed consent procedures continue.

IUDs are being strongly promoted in areas that have epidemic

rates of gonorrhea and chlamydia, along with skyrocketing

infertility rates. I have seen these IUDs inserted on the

floor (for lack of exam tables) in far from sterile

conditions in Nigeria, a part of the "infertility belt." In

many countries, pills are readily available over the counter

with little or no screening -- to women who are over 35,

obese, have sickle cell anemia, and/or diabetes (and often

there are no package inserts or decodable expiration dates).

Meanwhile, those methods that carry few or no intrinsic

health risks are hardly available (diaphragms, spermicides,

and in some regions, condoms). Many argue that there is

little demand for these methods, particularly where male

involvement in family planning is minimal and abortion is

illegal. These are important considerations we cannot

dismiss easily. But in fact, the high discontinuation rates

for the pill and IUD (often over 50 percent during the first

year of use) show that these methods do not meet women's

needs either. Furthermore, if the diaphragm had the benefit

of 10 15 years of heavy promotion the way other methods

have had in some countries, a sizable number of users would

probably accumulate.

Family planning professionals have often discouraged

traditional family planning methods such as breastfeeding,

abstinence, withdrawal, and rhythm. In the Philippines,

natural family planning methods have traditionally been very

popular, with rhythm consistently being one of the two most

widely used methods. Furthermore, 1980 data showed an 83

percent use-effectiveness for rhythm plus withdrawal. Yet

for a long time no one even knew how popular natural methods

were, because they are typically not even included as a

method on survey questionnaires. 9 In many cases, women stop

breastfeeding so they can take the pill -- based on the

advice of clinicians and/or the lack of availability of

methods that are not contraindicated during lactation. This,

of course, leads to higher infant mortality while replacing a

safe, relatively effective method of natural contraception

with one that costs money and carries risks.

In many cases, traditional sustained abstinence has been

replaced by "poor" contraceptive use and led to increased

birth rates. 10

I personally find myself in a dilemma when faced with

the question of which methods seem acceptable for export to

international programs. On one hand, the lack of male

support, lack of legal abortion, and health risk involved in

pregnancy for poor women can perhaps justify a greater level

of medical risk from contraception than seems acceptable in

the US. On the other hand, the opposite argument is just as

logical: the woman living in a developing country is more

likely to be anemic, has less access to emergency care, is

less likely to get a sexually transmitted disease diagnosed

or treated, and is less likely to be followed regularly to

screen for invisible but potentially dangerous deleterious

effects. So one can just as easily conclude that women in

developing countries face a compounded risk beyond the level

we accept for ourselves, and that only safe methods should be

subsidized and promoted.

One would like to assume that individual women can make

these decisions for themselves. Unfortunately, there is

considerable documentation of the lack of education and

counselling available in most family planning clinics in

developing countries. Side effects, risks, and danger signs

of high-tech methods are downplayed or ignored. Method

effectiveness is often exaggerated. It is not only the local

family planning worker who is to blame. Educational

materials produced by US and international agencies reinforce

this bias. And many US contraceptive manufacturers eliminate

part or all of the package insert information in their

overseas production. 11 Sexuality education is virtually

nonexistent.

Is it any wonder that women's satisfaction with

contraceptives turns out to be less than they had been led to

expect? Or that they don't stick with the methods they

"choose"?

A final issue of paramount concern when considering the

quality of care and how it affects family planning use is the

way poor women are often treated when they go to family

planning clinics in much of the Third World. Here the bulk

of the literature comes as no surprise to a veteran of the

women's health movement: women stand in lines two to four

hours or more to be seen, they are condescended to by

professionals of a different class, and finally the doctor

spends a fleeting moment with them (two minutes in a

Nicaraguan study, three minutes in Puerto Rico, and the time

in several Caribbean studies "could be measured in seconds

rather than minutes"). Women must present humiliating

"poverty certificates" to receive free care (Indonesia),

clinics are overcrowded, the hours are often terrible for

working women, drapes may be absent, confidentiality is

regularly violated, women must take off their underpants in

the hallway before going in to see the doctor (Morocco), and

nurses yell at and insult clients. The doctor generally

expects complete respect without returning it or even

fathoming that the client has both knowledge and experience
12,13,14
to help govern her family planning decision-making process.

Many of these problems stem from nationally or locally

determined policies rather than from international agencies.

And, of course, some programs incorporate a user perspective

to a limited degree. And there is no disputing that for all

the cultural restrictions, contraceptive side effects, and

disgraceful treatment, millions of women are still lining up

for hours, often without their husbands' knowledge or

consent, and coping with contraceptive side effects and

risks. They are undeniably desperate to control their

fertility.

What Is Quality of Care? -- A Feminist Model

What kind of internationally funded family planning

could the women's movement support? What is our vision of

quality care in the context of the "developing" world?

Any attempt to answer this question must begin with the

minimum goal for a program: to serve the reproductive health

needs of women. Norma Swenson of the Boston Women's Health

Book Collective elaborates on that goal with a basic

description of what quality care encompasses:

"In both the industrialized and developing world
we value women's right to reproductive choice and
we are committed to the highest quality and widest
range of choice of reproductive health services
for all women, without coercion, incentives, or
undue persuasion. We are equally committed to
making available the most complete information we
have about reproductive health and human
sexuality, as a matter of human rights and
informed consent. Such information includes
risks, benefits, and short- and long-term
consequences, both intended and unintended. Such
human rights inevitably include the right of free
refusal of any and all services or products. We
believe these values need to be further explored,
elaborated, and given more concrete substance."1-

A similar, more structural perspective to quality care

has recently been proposed by Adrienne Germain (of the

Population Council and the International Women's Health

Coalition). Her "reproductive health approach" involves

population and child survival professionals together with

women's groups, incorporates improved standards of care,

maternal health interventions, children's services, and

advocacy, education, and referral. Germain suggests that

"improved quality" would mean providing full information,

treating clients with respect, and following them up.6

This comprehensive service delivery model approximates

that which has long been advocated, and, indeed, implemented

by a number of women's groups in this country.

Limited examples do exist in the developing world of

programs that reflect this philosophy and structure. In

fact, the same tax dollars that help support Planned

Parenthood services support a few such "alternative" models

in the developing world.

One such example is the Centro de Desarrollo de Mujer,

in a village near Guadalajara, Mexico. This project has

received funds from Pathfinder and from the Mexican social

security system. As its director, Silvia Flores, explains,

"We don't go out into the village and talk to women about the

pill or the condom. We go out and ask women about their

lives, their families, what needs they have that we can

address. We are there to serve the poor women in our

village." 17 Education and counselling about all methods are

done by women from the same socioeconomic class and from the

same or a nearby village. The Centro is small but has had a

steadily growing number of women requesting contraception.

Another interesting program is the Bangladesh Women's

Cooperative Program in Bangladesh. Based on an understanding

of women's real life conditions, its goal has been to create

the demand rather than the supply of family planning.

Women's cooperatives were established to allow women to

initiate income-generating projects. In addition, they were

to serve as a channel for information about health,

nutrition, and family planning, as well as for teaching

literacy. This project actually changes the culture in ways

that empower women and create a different context for

decisions about many issues -- marriage, work, children, and

family planning. The project reports a phenomenal 66 percent

of "eligible" (married 15 44 years, at least six months

post partum, husband present) women contracepting and 31

percent of all women doing so.

A popular program in Colombia, SI-Mujer, is founded on

the basic goal of "promoting social change, to try to have

each woman leave a somewhat different person." They provide

family planning and pregnancy counselling, self-health

education including classes on sexuality and on "being alone"

for the older woman. They are increasingly self-sufficient

(and wary of international funds), although they have

received support from the Population Crisis Committee, the

Development Services International (Canada) and the

International Women's Health Coalition.

Projects like the Centro de Desarrollo de Mujer, SI-

Mujer, and the Bangladesh Women's Cooperative signify a

different breed of family planning program. Their existence

stands as evidence of what can work and their success

(despite relatively limited funding) is the best rebuttal to

the argument that "feminist models aren't appropriate in

developing countries." Unfortunately, these model programs

are few in number, generally small, and often ignored in the

literature. As a result, the international user-oriented

program has remained a marginal phenomenon and "quality care"

has remained a nebulous, seemingly undefinable concept in the

international context.

Why has quality care eluded formal definition and

contract language in international family planning? The

primary reason is that feminism has not had any organized

influence on international family planning agencies, and even

less on national family planning policies in the Third World.

The meaning of quality of care is no enigma in US family

planning programs, where women's organizing has been

instrumental in defining and guaranteeing quality health

care. It is in fact spelled out in great detail by Title X

(federal) and a number of state regulations, which govern the

funding of family planning programs that receive public

funds. Because these domestic programs (which include many

Planned Parenthoods, feminist clinics, and county agencies)

represent some of the best medical care to be had in America,

it is worthwhile examining how state regulations define the

quality of care they demand of all grantees.

The guidelines governing publicly funded family planning

clinics in the US state that the purpose of family planning

services is to provide clients with clinical services,

education, and counselling that enable them to reach and

implement an informed decision regarding the choice and

continued use of family planning methods and services. The

counselling session is designed to resolve uncertainty,

ambivalence, and anxiety in relation to reproductive health

and to enhance clients' capacity to arrive at a decision that

reflects their continued self-interest. Written materials

must be provided in the client's first language if more than

10 percent of the country speaks that language as a first

language. The procedures involved in the clinic visit must

be explained. Tests for anemia, gonorrhea, and cervical

cancer are performed routinely along with physical

examination of the breasts, reproductive organs, and thyroid;

various additional laboratory tests and treatments as needed

are covered by tax dollars, for example for many sexually

transmitted diseases. Clinics must offer virtually all of

the currently available methods. The rights of the consumer

must be clearly posted: these include the right to privacy,

to change one's mind, to be treated respectfully, etc.

Agencies are required to have built-in systems for client

feedback, including consumer advisory boards. Basic

screening and counselling must be available for pregnancy,

infertility, sexuality, and sexual abuse. Furthermore,

clinics are in danger of losing their funding if monitoring

visits show that the quality of the education, counselling,

medical exam, physical facility, or administrative system is

not up to the level of quality stipulated. These standards

of care are quite detailed and specific, making up an entire
18,19
manual. And substantial funding is allocated toward training

staff to implement them ably. Clearly, ensuring quality care

in domestic family planning programs is a serious commitment.

Yet no one seems to challenge the feasibility or value of

this commitment to making clients' needs the bottom line. In

US family planning, a user-perspective is the law.

Feminism has influenced the basic design of domestic

family planning programs as well, by continually

rearticulating the changing needs of women. For example,

adolescents can increasingly get care at comprehensive,

school-based programs that also provide general health

screening, crisis counselling, job counselling and other

services. Special services exist for lesbian women. And

some family planning money has gone to support sex education

programs, sexual abuse projects, and teen mother services.

Domestic family planning programs are certainly not perfect,

and they are currently losing much of their progressive tone

and funding under the political muscling of the New Right.

But two decades of feminist participation in domestic policy

formation and implementation has ensured that the cultural

and personal needs of women are actually reflected in service

design and delivery.

Strategies for Improving Quality of Care

Many have suggested that implementing standards of care

anything like the domestic ones is completely unrealistic for

the developing world, both logistically and culturally. I

would argue that they provide a far better starting point

than single-method .programs implemented with poorly trained

staff, which provide little education or counselling and less

clinical care, and treat the client like an extension of her

contraceptive method.

Yet, despite the poor quality of most international

family planning programs, women around the world do want

access to birth control. And despite the New Right,

population funding remains intact and population programs

will continue. I believe that our goal as women's health

activists should be to improve rather than eliminate

internationally funded family planning programs, to help make

them more responsive to the priorities of women and less

responsive to the priorities of those concerned with

fertility rates.

The obvious question is whether we can have any real

impact. I would argue that we can, and for several reasons.

First, the population establishment may be willing to address

the women's priorities seriously, even if in large part

because it is the surest route to attracting clients and

ultimately meeting its demographic priorities. Second, there

is a core of individuals working within population agencies

who are deeply committed to quality care issues and have in

fact embarked on a number of quality-care projects. Third,

there is a growing feminist consciousness among many women

(providers and consumers) in developing countries who are

articulating their concerns directly. The feminist critique

of neo-Malthusianism and unsafe contraceptive use is actually

being co-opted by the Right in their attack on international

family planning; against a backdrop of the highly visible New

Right espousing our concerns in a distorted form, the public

voice of the women's health movement has become less audible.

We need to pursue avenues inside the system for creating

change as well as outside.

On October 8 and 9, 1986, the Population Council and the

International Women's Health Coalition cosponsored a second

meeting to advance the dialogue between the international

family planning establishment and the US women's health

movement. Part of the purpose of this meeting was to learn

more about what quality care might look like in the

international context, and what it would take to bring it

about. We can look more carefully at some model programs,

learn about how quality is determined at the international,

national, and local levels, and more about the lives and

needs of women around the world. And we can explore what the

specific contribution of US feminists might be in improving

international family planning.

What are the major changes needed to bring about the

kind of quality family planning care that feminists could

support? Below is a series of measures that would greatly

improve US-funded family planning services.

A. Involve local women's groups extensively in planning,

implementation, and evaluation of programs. It is obvious

that the most successful program is one in which the users

feel some "ownership." As the Bangladesh Income-Generation

project slogan goes, "Rural women know more about their lives

than we do." The Population Council is currently involved

in a project in Latin America designed to gather input from

local women's groups and grass roots providers for policy-

makers. These are interesting adaptations of the domestic

practice of consumer advisory boards for every clinic.

B. Give more attention and funding to comprehensive

programs that:

1) Seek to empower women in culturally viable ways and

expand their possibilities for making choices about their

lives. Locally controlled women's income-generation

projects, literacy programs, and grass roots community

organizing (not to mention legalizing abortion) can all

change women's consciousness and objective options.

2) Provide funds for maternal and child

health/reproductive health services, including for

infertility care, rather than just family planning. While

the benefits of the comprehensive model have been extensively

discussed, massive funding for such a model would require a

major policy shift.

Where international population programs have attempted

to address larger health and development issues, efforts have

usually been token. For example, several years ago, many

international family planning programs began to include oral

rehydration therapy components. An example of this

"integration" is a training curriculum I was given in 1985

for Nigeria: out of a five-week training course, two hours at

the end were devoted to oral rehydration therapy.

C. Incorporate higher standards of medical care, including:

1) Screening

Screening provides no guarantee that a woman will not

have serious or minor side effects from a contraceptive. And

it should not replace a counselling session that elicits the

woman's previous experience with a method. However, there is

no getting around the fact that a woman with severe anemia or

an active cervical infection is a poor candidate for an IUD

insertion or that one with high blood pressure should not

take the pill. Aside from its obvious benefit in terms of

identifying contraceptive contraindications, the value of

testing for anemia and cervical cancer per se in all women is

not trivial. There has been no real discussion among

feminists about the benefits and risks of over-the-counter

contraceptive distribution, but its virtual elimination of

any health screening is some cause for concern.

2) Increased number of methods available

The type and not only the number of methods should be

increased. There is no harm in ordering and distributing a

small number of condoms or implants if it reflects the demand

of an informed user population. There are about ten

different methods currently available. If 5 10 percent of

a clinic population is interested in a particular method,

that merits the clinic's supplying that method.

3) Informing all clients of their right to change

methods whenever they feel that such change will best serve

their family planning needs. This attitude should be

reflected in educational materials, client-provider

transactions, and the availability of various methods.

4) Standards for over-the-counter and community-based

distribution

Contraceptive dispensing "in the streets" (e.g., by

pharmacy workers and village outreach workers) must be

accompanied by decent screening and counselling. If it can,

then such distribution programs may offer women preferred

alternatives to distant clinics. If it cannot, the

acceptability of such schemes must be questioned.

5) Funding continuation dependent on evaluation of

quality care

Compliance with comprehensive written standards can be

evaluated in a number of ways. Observation of client-

provider transactions (including the medical exam), medical

chart audits, and adherence to medical protocols are all

proven techniques. Educational materials should be

evaluated, contraceptives in the dispensary should be checked

for expiration dates, hygiene conditions examined.

In addition, program reviews should involve input from

consumers. A variety of mechanisms for soliciting such input

could be tested: user dropout rates and method

discontinuation rates should be evaluated, local women's

councils could be funded to collect documentation on quality

of services, consumer advisory boards could file reports,

limited community surveys could be conducted. The need for

this kind of information cannot overemphasized. We know that

many family planning clients in the developing world have no

formal avenues or cultural support for airing their concerns;

we also know that serious problems in quality of care exist.

Real improvement in developing a user-perspective cannot be

made without the participation of the users.

D. Revise training programs to include quality of care

issues as a fundamental principle

The user-perspective is the backbone of quality family

planning in the US; yet it is virtually absent from the

curricula of many international family planning training

programs. Quality care issues should be a fundamental part

of such training programs, both for clinicians and for admin-

istrators.

E. Fund research on abortion and maternal morbidity-

mortalith. gynecologicall infections, sexuality_ and

documentation of experimental programs

What percent of women getting pills over the counter

actually have contraindication? Do they know this? What is

the PID rate associated with IUD use in areas of high

infertility? Where is chlamydia a problem (both

geographically and demographically)? Regarding periodic

abstinence associated with natural family planning, is it a

respite from unwanted but otherwise obligatory sex; is it a

restriction on real sexual enjoyment; or is such abstinence

not even feasible because women have no right to refuse sex

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